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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH123609 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The investigators are modifying and testing the preliminary effectiveness and implementation of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit clients receiving services at a community mental health setting who have a schizophrenia spectrum disorder and recent suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks. Providers will be recruited and trained to deliver the intervention. Both clients and providers will be assessed at baseline to test our approach to measurement prior to the Aim 2 RCT (registered separately). Clients will be assessed at three additional timepoints (middle of treatment, end of treatment, and 2 months after treatment ends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBSPp | Experimental | Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Suicide Prevention for psychosis CBSPp) | Behavioral | Cognitive and behavioral approach to suicide prevention among individuals with psychosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Calgary Depression Rating Scale (CDRS) | A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors. | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
| Positive and Negative Symptom Rating Scale (PANSS) | A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms. | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | A scale to measure suicide thoughts and behavior. The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent) | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Hopelessness Scale | A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present. | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Upload to NIMH Data Archive
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A total of eight clients consented to participate in the Aim 1 open pilot study and were subsequently scheduled to attend a screening assessment. One individual was not eligible per the screening assessment, and two individuals did not attend the scheduled screening assessment.
As a result, five individuals were eligible to participate and began treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBSPp | Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions. Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis. In this open pilot trial, all participants received the treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBSPp | Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions. Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Calgary Depression Rating Scale (CDRS) | A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors. | Posted | Mean | Standard Deviation | score on a scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
|
Adverse event data collected across participant involvement in study (beginning with the eligibility screener and ending after follow-up assessment): Approximately across 5 months per participant
Systematic Assessment of Adverse Events: Routine determination of adverse events through standard assessment at each study timepoints by research staff, project coordinator, or principal investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBSPp | Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions. Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis. In this open pilot trial, all participants received the treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety during assessment | Psychiatric disorders | Systematic Assessment |
This was an open pilot trial, therefore no randomization occurred nor comparison between receiving treatment or not. All participants received treatment. The next phase of our study (Aim 2; registered separately) will report on the RCT.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Bornheimer | University of Michigan | (734) 615-2915 | bornheim@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2021 | Mar 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2021 | Mar 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D011618 | Psychotic Disorders |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| The Entrapment Scale | A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped. | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
| The Defeat Scale | A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated. | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Lifetime History of Suicide Attempt | Count of Participants | Participants |
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| Past Week Suicide Attempt | Count of Participants | Participants |
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| Past Week Suicide Ideation | Count of Participants | Participants |
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| Past Week Suicide Plan | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Positive and Negative Symptom Rating Scale (PANSS) | A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms. | Posted | Mean | Standard Deviation | score on a scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
|
|
|
| Primary | Columbia-Suicide Severity Rating Scale (C-SSRS) | A scale to measure suicide thoughts and behavior. The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent) | One individual at post-treatment did not complete the assessment with research staff | Posted | Count of Participants | Participants | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
|
|
|
| Secondary | Beck Hopelessness Scale | A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present. | Posted | Mean | Standard Deviation | score on a scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
|
|
|
| Secondary | The Entrapment Scale | A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped. | Posted | Mean | Standard Deviation | score on a scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
|
|
|
| Secondary | The Defeat Scale | A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated. | Posted | Mean | Standard Deviation | score on a scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) |
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| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
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| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
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| Mid-treatment positive sub scale |
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| Mid-treatment negative sub scale |
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| Mid-treatment general sub scale |
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| Post-treatment positive sub scale |
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| Post-treatment negative sub scale |
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| Post-treatment general sub scale |
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| Follow-up positive sub scale |
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| Follow-up negative sub scale |
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| Follow-up general sub scale |
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| Baseline suicide plan |
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| Baseline suicide attempt |
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| Mid-treatment suicide ideation |
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| Mid-treatment suicide plan |
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| Mid-treatment suicide attempt |
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| Post-treatment suicide ideation |
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| Post-treatment suicide plan |
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| Post-treatment suicide attempt |
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| Follow-up suicide ideation |
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| Follow-up suicide plan |
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| Follow-up suicide attempt |
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| Title | Measurements |
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| Follow-up |
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| Title | Measurements |
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| Follow-up |
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| Title | Measurements |
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| Follow-up |
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